A Study Comparing The Safety, Tolerability and Efficacy of Trizivir VS Combivir & Atazanavir In Subjects With HIV

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The aim of this study was to assess whether TRIZIVIR, administered twice-daily was as safe, tolerable and efficacious as a combination of the drugs COMBIVIR administered twice-daily and atazanavir administered once daily. Over the course of 48 weeks, various parameters that measure safety, tolerability and efficacy of the investigational drugs were measured and compared.

The primary endpoint was drug efficacy, measured as the proportion of study subjects who had plasma HIV-1 RNA less than 50 copies/mL at week 48 and did not meet the definition of virologic failure through this timepoint. [ Time Frame: 48 Weeks ]

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion criteria:

Adults with documented HIV-1 infection.

Past use of HIV drugs must have been less than 15 days.

Plasma HIV-1 RNA between 500 and 20,000 copies/mL.

CD4+ cell count greater than 100 cells/mm3.

Willing/able to provide written informed consent.

Exclusion criteria:

Have AIDS at screening.

Pregnant or breastfeeding.

Underlying medical conditions considered to be significant for this protocol.

Participating in other investigational drug trials.

In the opinion of the investigator, would be unable to complete 48 weeks of dosing.